Review ArticleReview
Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?
Anthony M. Cundell
PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 386-393; DOI: https://doi.org/10.5731/pdajpst.2014.00997
Anthony M. Cundell
Consulting Microbiologist, Scarsdale, NY

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In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 5
September/October 2014
Bacterial Endotoxin Requirements for Dry Powder Inhalants and Their Excipients: Are They Critical Quality Attributes?
Anthony M. Cundell
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 386-393; DOI: 10.5731/pdajpst.2014.00997
Jump to section
- Article
- Abstract
- Introduction
- Occupational Exposure to Bacterial Endotoxins
- Bacterial Endotoxin Assays
- Bacterial Endotoxins Specifications for Excipients and Drug Product
- 1. Review of the Endotoxins Requirements for Other Inhalation Products and Their Excipients
- 2. Comparison of the Normal Endotoxins Exposure to the Dosage Level Obtained When Using an Inhaler
- 3. Determining the No-Effect Level and Using It to Set an Endotoxin Requirement
- Bacterial Endotoxin Specification for DPIs
- Environmental Endotoxins
- Recommendations
- References
- Figures & Data
- References
- Info & Metrics
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